Latest news with #OSEImmunotherapeutics
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a day ago
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UPDATE ON THE TERMS OF THE SHAREHOLDERS GENERAL MEETING
UPDATE ON THE TERMS OF THE SHAREHOLDERS GENERAL MEETING Nantes, June 9th, 2025, 8 a.m. - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) informs its shareholders and the market of the update on the terms of the Combined General Meeting scheduled for 25 June 2025 (the 'General Meeting'). In preparation of the General Meeting, OSE Immunotherapeutics has formally submitted to the President of the Nantes Commercial Court a request to extend the date of the General Meeting. The purpose of this approach is to ensure that the General Meeting is held in a regular and transparent manner and that shareholders are properly informed. It is in response to requests made by some of the Company's shareholders, in a context marked by the filing, by a group of shareholders acting in concert, of several resolutions aimed at substantially changing the composition of the Board of Directors. Furthermore, the communication of these resolutions to the market did not occur in a timely manner nor under conditions ensuring, at this stage, that shareholders are fully and fairly informed or that the General Meeting is properly or regularly held. In this respect, the resolutions presented by the group of shareholders acting in concert and which have not been approved by the Board of directors are not identified clearly enough on the voting form posted on the Company's website on June 4th, 2025. The Company indicates that the resolutions of this group of shareholders, on which the Board of Directors recommends voting against, are renumbered A to K (instead of resolutions n°35 to 44). Apart from this renumbering, all the resolutions remain unchanged. An amended convening notice will be published in the official legal bulletin. The voting form along with the preparatory documents for the General meeting required by Article R. 22-10-23 of the French Commercial Code, as amended to include this renumbering, are available on the Company's website: OSE Immunotherapeutics considers that the current situation as described above and in the press release dated June 4th, 2025 raises significant legal uncertainties, which justify referring to the judge to extend the date of the General Meeting in order to secure the voting process and ensure that shareholders are consulted in an orderly fashion. OSE Immunotherapeutics affirms its determination to protect the interests of all its shareholders and to defend the transparency and integrity of its governance, in compliance with the legal and regulatory framework. OSE Immunotherapeutics will communicate in due course on the progress of this procedure. ABOUT OSE IMMUNOTHERAPEUTICS OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I) that address the unmet patient needs of today and tomorrow. We partner with leading academic institutions and biopharmaceutical companies in our efforts to develop and bring to the market transformative medicines for people with serious diseases. OSE Immunotherapeutics is based between Nantes and Paris and is quoted on Euronext. Additional information about OSE Immunotherapeutics assets is available on the Company's website: Follow us on LinkedIn. Contacts Fiona Dé French Media Contact FP2COMFlorence Portejoiefportejoie@ 6 07 768 283 U.S. Media ContactRooney Partners LLCKate Barrettekbarrette@ 212 223 0561 Forward-looking statementsThis press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics' management considering its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as 'expect', 'anticipate', 'believe', 'target', 'plan', or 'estimate', their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics' shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on April 30, 2025, including the annual financial report for the fiscal year 2024, available on the OSE Immunotherapeutics' website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements. Attachment EN_250509_Update GM
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6 days ago
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OSE Immunotherapeutics strengthens Growth Strategy: Accelerates key pillars of Inflammation and Immuno-Oncology
Figure_1 OSE Immunotherapeutics strengthens Growth Strategy: Accelerates key pillars of Inflammation and Immuno-Oncology Ignites strong momentum in immunology & inflammation pipeline through lusvertikimab development, leveraging a new predictive biomarker. Leads a new era in cancer vaccines with Tedopi® on track for registration. Drives company transformation through responsible governance: international development, rigorous financial planning and clinical execution. NANTES, France – June 4th, 2025, 8:00 am CET - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), a biotech company dedicated to developing first-in-class therapies in immuno-oncology and immuno-inflammation, today outlined the company's ambition for long-term growth and sustainable shareholder and societal value. Nicolas Poirier, CEO of OSE Immunotherapeutics notes: "OSE's grounding in solid science, our collaborative approach and a skilled workforce have resulted in a transformative two years, progressing our mission to bring breakthrough immunotherapies to the clinic. We are proud of our accomplishments, particularly delivering positive results for our lead assets, lusvertikimab and Tedopi®, which hold the potential to redefine standards of care across multiple diseases in I&I and I/O. We also secured new partnerships for our preclinical programs and significantly strengthened our financial position with over €90 million in new non-dilutive funding. OSE is positioned among Europe's leading biotechs. Now, it's time to build a more ambitious international company and unlock greater long-term value for all stakeholders.' OSE Immunotherapeutics' Board of Directors, led by Chairman, Didier Hoch, commented: 'Under the joint leadership of the Board and Executive Team, OSE has shown resilience and growth in a competitive biotech landscape. The company is entering a decisive phase. Our strategy is built on three pillars: maintaining scientific leadership, expanding strategic alliances, and ensuring disciplined financial management for sustainable growth. To achieve this, the company will explore various options, including business development, strategic alliances, international investments, and a potential Nasdaq listing. We are shaping the future by building an ambitious international biotech, driven by innovation creating lasting value for patients, employees, and shareholders.' New predictive biomarker with potential to revolutionize UC treatment, an emerging value lever for lusvertikimab Despite intensive therapeutic research in IBD, only 25–30% of UC patients currently achieve clinical remission, and this limitation—commonly referred to as the therapeutic ceiling (Vieujean S. Nature Reviews Gastroenterology, 2025)—persists across all approved therapies and drug classes in late-stage development. OSE research and translational teams, in collaboration with foundational model specialists, have identified a predictive biomarker that can isolate a subpopulation of patients (~30%) and offer significantly enhanced treatment outcomes, potentially achieving clinical remission rates exceeding 50%. This biomarker-driven approach was developed using advanced AI and transfer learning. The model was trained on multimodal data from millions of chronic inflammatory disease patients and refined with data from CoTikiS Phase 2 study. Importantly, biomarker-negative patients showed 0% clinical remission in this dataset, indicating no loss of treatment opportunity when prioritizing treatment based on biomarker status. This precision medicine approach could position lusvertikimab as a first-line therapy for the biomarker-positive population; a potential addressable market opportunity exceeding $3 billion across seven major markets. Next steps include prospective validation of this predictive biomarker through stratification in future clinical trials. Nicolas Poirier details: 'Our comprehensive dataset for lusvertikimab, with its novel upstream mechanism demonstrating clinical efficacy and good safety supports development in UC and other autoimmune diseases. The identification of a predictive biomarker is a breakthrough, suggesting that around 30% of UC patients could achieve remission rates over 50%. This reinforces lusvertikimab's potential as a monotherapy in UC and acts as an additional catalyst to accelerate development. We are designing a Phase 2b program to demonstrate efficacy by 2027, establish the dose for registrational studies, explore a subcutaneous formulation, and validate the predictive biomarker.' Commenting on OSE's progress in Tedopi, Nicolas Poirier adds: 'Earlier this week, we shared our progress with Tedopi® (link to press release). To summarize, our pivotal Phase 3 program in NSCLC with Tedopi® is progressing well, keeping us in the race to register the first therapeutic cancer vaccine. Enrolment is advancing across 144 clinical sites in Europe and North America and is on track to complete in the second half of 2026. The data readout is expected in 2027. The recent positive results in pancreatic cancer highlight the growing momentum behind therapeutic cancer vaccines. We are looking forward to additional Phase 2 readouts in combination with anti-PD1 from our ovarian and lung cancer trials in 2026.' Nicolas Poirier concludes: 'OSE is at the forefront of transformative scientific breakthroughs in areas of critical unmet medical need. I am convinced that the company is at a turning-point, with a clear international trajectory toward value creation and long-term impact. With strong science, strategic focus, and a robust diversified pipeline, OSE is uniquely positioned to deliver meaningful returns for shareholders—while transforming outcomes for patients worldwide.' DOCUMENTS MADE AVAILABLE TO SHAREHOLDERSThe convening brochure for the combined shareholders' meeting of June 25, 2025, now available on the Company's website ( is an essential tool for understanding the strategy pursued by the Board of Directors, informing shareholders and facilitating their voting decision. The related press release, presenting the context of the combined shareholders' meeting and the Board's position on all resolutions, is also available here: ABOUT COTIKIS The CoTikiS study, a 50-week randomized, double-blind, placebo-controlled trial, included a 10-week induction period evaluating two doses (450 mg or 850 mg) of lusvertikimab versus placebo; followed by a 24-week open label extension (OLE) with 850 mg infusions every four weeks; and a 16-week safety follow-up. Findings from the induction phase, presented at the 2025 ECCO congress, showed both doses met the primary efficacy endpoint (improvement in Modified Mayo Score at Week 10) and demonstrated significant results on secondary endpoints. The study highlights lusvertikimab's potential as a first-in-class monotherapy with a novel mechanism of action in the treatment of chronic and inflammatory diseases. Clinical and preclinical data were presented at ECCO 2025 and Digestive Disease Week (DDW) in May 2025, showing high rates of clinical and endoscopic remission, histological improvement and Histo-Endoscopic Mucosal Improvement (HEMI) with a favorable safety profile. Early efficacy signals in both biologic-naïve and experienced populations suggest rapid onset of effect, indicating potential as a first-line biologic or for patients resistant to anti-TNF and anti-IL-12/23 therapies. OLE data shows over 90% of UC patients who achieved a clinical response after 10 weeks maintained symptomatic remission for an additional 24 weeks, with 61% of those not in remission after 10 weeks achieving it after a further 24 weeks on the 850 mg dose. Lusvertikimab was well tolerated over the extended treatment period. ABOUT OSE IMMUNOTHERAPEUTICS OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I) that address the unmet patient needs of today and tomorrow. We partner with leading academic institutions and biopharmaceutical companies in our efforts to develop and bring to the market transformative medicines for people with serious diseases. OSE Immunotherapeutics is based between Nantes and Paris and is quoted on Euronext. Additional information about OSE Immunotherapeutics assets is available on the Company's website: Follow us on Fiona Dé French Media Contact FP2COMFlorence Portejoiefportejoie@ 6 07 768 283 U.S. Media ContactRooney Partners LLCKate Barrettekbarrette@ 212 223 0561 Forward-looking statementsThis press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics' management considering its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as 'expect', 'anticipate', 'believe', 'target', 'plan', or 'estimate', their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics' shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on April 30, 2025, including the annual financial report for the fiscal year 2024, available on the OSE Immunotherapeutics' website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements. Attachments Figure_1 EN_250604_Bold Strategic Vision press release_vf3
Yahoo
02-06-2025
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OSE Immunotherapeutics Provides Clinical Updates on Neo-Epitope Based Cancer Vaccine Tedopi® in Pancreatic Cancer and Non-Small Cell Lung Cancer
OSE Immunotherapeutics Provides Clinical Updates on Neo-Epitope Based Cancer Vaccine Tedopi® in Pancreatic Cancer and Non-Small Cell Lung Cancer Two presentations at the American Society of Clinical Oncology (ASCO) 2025: TEDOPaM - Phase 2 first positive results in advanced pancreatic cancer: Oral communication presented by the French GERCOR Oncology Group, trial sponsor. ARTEMIA - International pivotal Phase 3 study in Non-Small Lung Cancer (NSCLC): Trial in Progress. NANTES, France – June 2, 2025, 6:00pm CET - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), today provided clinical updates on Tedopi®, the 'off-the-shelf' neo-epitope-based therapeutic cancer vaccine under evaluation in both monotherapy and combination therapy across five clinical trials in several cancer indications. Silvia Comis, MD, Chief Clinical and Medical Research Officer OSE Immunotherapeutics, commented: 'We are pleased to share the latest clinical updates on our cancer vaccine Tedopi® at the ASCO Annual Meeting. Tedopi® combines 10 neo-epitopes derived from five tumor antigens, selected for their presence in a range of tumors, offering a multi-target 'pipeline in a product' approach for HLA-A2 positive patients to address unmet needs in oncology. The positive results for Tedopi® in pancreatic cancer are promising for this devastating disease with a poor prognosis. We extend our gratitude to the GERCOR Oncology Group and the PRODIGE Intergroup, sponsors of the TEDOPaM study, for presenting these encouraging results at ASCO. In lung cancer, patient recruitment is progressing per plan in the Artemia Phase 3 registration study, a key milestone bringing us one step closer to the registration of Tedopi® for NSCLC. As previously communicated, the readouts of the combination Phase 2 trials, CombiTED for NSCLC and TEDOVA for ovarian cancer, are expected in 2026.' TEDOPaM - An oral communication, titled (abstract 4009) featuring positive topline Phase 2 results for the clinical trial TEDOPaM was presented by the GERCOR Oncology Group at ASCO 2025. TEDOPaM is a randomized, non-comparative, Phase 2 trial evaluating FOLFIRI1 (Arm A) and cancer vaccine Tedopi® (OSE2101) plus FOLFIRI chemotherapy (Arm B) as maintenance treatment in HLA-A2 positive patients with advanced or metastatic Pancreatic Ductal Adenocarcinoma (PDAC) with no progression after eight cycles of FOLFIRINOX induction chemotherapy2. The primary endpoint of the trial was the one-year overall survival (OS) rate in the experimental Arm B (Fleming 2-stage design, H0: 25%; H1: 50%, 1-sided alpha: 2.5%, power: 90%). 107 patients (53 patients in Arm A and 54 patients in Arm B) were enrolled (NCT03806309). The TEDOPaM trial met its primary objective, showing positive outcomes according to the predefined statistical hypothesis, with a 12-month OS of 65% in Arm B, and minimal toxicity for Tedopi® combined with FOLFIRI as maintenance treatment. Two complete responses were observed when adding Tedopi®. No new safety signal was observed. Prof. Cindy Neuzillet, MD, PhD (Curie Cancer Research Institute, Saint-Cloud), Principal Investigator of the TEDOPaM study stated: 'These results are an encouraging first step towards better understanding the contribution of Tedopi® in combination therapy in advanced pancreatic cancer. We now need more mature data on overall survival over a longer period. A translational and biomarker program is also underway to identify patient profiles likely to benefit from this maintenance treatment involving a neo-epitope-based cancer vaccine. Thanks to the digestive oncology community for their support in this research, which helps us better understand this disease.' Detailed results: A total of 107 patients were randomized between April 2021 and May 2023. The median age was 64 years, with 53% men and 69% having metastases. The median number of Tedopi® injections was 7.5. At the data cut-off on December 9, 2024, the median follow-up was 21 months. The TEDOPaM study met its primary endpoint: M12-OS was 65% in Arm B (FOLFIRI + Tedopi®). With a median follow-up of 21 months, around 35% of death events were observed. An unexpectedly long OS was observed in these PDAC patients with disease control after induction FOLFIRINOX: median OS of 17 months in control Arm A (versus 10-12 months expected). Two complete responses were observed when adding Tedopi® in Arm B, and none in control Arm A with chemotherapy alone. Safety: 26% in Arm B reported serious adverse events (SAEs). 6% related to Tedopi®. No new safety signal was reported. Further follow-up for OS and safety data is ongoing. A comprehensive translational analysis (IMMUNOPANC-Sign program) is ongoing. ARTEMIA - A 'Trial in Progress' poster titled: was also presented at ASCO 2025. The Phase 3 pivotal clinical trial aims to support the registration of Tedopi® as a second-line treatment in HLA-A2 positive NSCLC patients with secondary resistance to anti-PD-(L)1 immunotherapy. This pivotal trial is conducted in 14 countries across the United States, Canada, Europe, and United Kingdom. ARTEMIA will include 363 patients and enrolment is progressing according to the study program (NCT06472245). ABOUT RESECTED PANCREATIC DUCTAL ADENOCARCINOMA (PDAC). Resected pancreatic ductal adenocarcinoma (PDAC) is a highly aggressive form of cancer originating in the ducts of the pancreas. It represents about 95% of all pancreatic cancers. The global burden of pancreatic cancer has more than doubled in recent decades. It is now the sixth leading cause of cancer-related death worldwide, with an estimated 510,922 new cases and 467,409 deaths in 2022. The incidence of the disease continues to rise annually, with projections indicating a 95.4% increase in new cases by 2050, potentially reaching a total of 998,663 new cases globally. The overall five-year survival rate for pancreatic cancer is 10% worldwide, with only modest improvement in the past decade3. Pancreatic cancer is now the 10th most found cancer in the US4 and represents about 3.5% of all new cancer diagnoses, and 7.1% of all cancer deaths in the EU5. Surgical resection is the only potential curative treatment for PDAC, but it's feasible for only 15-20% of patients at diagnosis due to the advanced stage of their disease6. Even with successful surgery, the prognosis remains poor, with a high likelihood of recurrence. Advances in neoadjuvant therapies, which are treatments given before surgery, have improved the chances of achieving a margin-negative resection, meaning no cancer cells are found at the outer edge of the removed tissue. However, long-term survival rates remain low, underscoring the need for continued research and development of more effective systemic therapies to improve outcomes for patients with resected PDAC7. ABOUT GERCOR GERCOR is a multidisciplinary association dedicated to clinical research in oncology whose purpose is to improve the care of patients affected by cancer by developing clinical research in the scope of an independent, multidisciplinary and multi-focused cooperative group. GERCOR concentrates its efforts on only one mission: clinical research. Thanks to its network, GERCOR offers patients easy access to its up-to-date treatments. To achieve this goal, GERCOR has all the logistical structure needed to carry out the trials it promotes. ABOUT OSE IMMUNOTHERAPEUTICS OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I) that address the unmet patient needs of today and tomorrow. We partner with leading academic institutions and biopharmaceutical companies in our efforts to develop and bring to the market transformative medicines for people with serious diseases. OSE Immunotherapeutics is based between Nantes and Paris and is quoted on information about OSE Immunotherapeutics assets is available on the Company's website: Follow us on LinkedInContacts Fiona Dé French Media Contact FP2COMFlorence Portejoiefportejoie@ 6 07 768 283 U.S. Media ContactRooney Partners LLCKate Barrettekbarrette@ 212 223 0561 Forward-looking statementsThis press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics' management considering its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as 'expect', 'anticipate', 'believe', 'target', 'plan', or 'estimate', their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics' shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on April 30, 2025, including the annual financial report for the fiscal year 2024, available on the OSE Immunotherapeutics' website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements. 1 FOLFIRI: A combination chemotherapy with folinic acid, fluorouracil and irinotecan2 FOLFIRINOX: A combination chemotherapy with folinic acid, fluorouracil, irinotecan and oxaliplatin3 Trends in the Global Incidence of Pancreatic Cancer and a Brief Review of its Histologic and Molecular Subtypes | Journal of Gastrointestinal Cancer4 American Cancer Society: Annual Cancer Facts & Figures | American Cancer Society | American Cancer Society5 European Network of Cancer Registries: Pancreatic_Cancer_2022_ENG.pdf6 A neoadjuvant therapy compatible prognostic staging for resected pancreatic ductal adenocarcinoma | BMC Cancer | Full Text7 A neoadjuvant therapy compatible prognostic staging for resected pancreatic ductal adenocarcinoma | BMC Cancer | Full Text Attachments EN_250602_Post ASCO_vf EN_250602_Post ASCO_vfError in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
02-06-2025
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OSE Immunotherapeutics Provides Clinical Updates on Neo-Epitope Based Cancer Vaccine Tedopi® in Pancreatic Cancer and Non-Small Cell Lung Cancer
OSE Immunotherapeutics Provides Clinical Updates on Neo-Epitope Based Cancer Vaccine Tedopi® in Pancreatic Cancer and Non-Small Cell Lung Cancer Two presentations at the American Society of Clinical Oncology (ASCO) 2025: TEDOPaM - Phase 2 first positive results in advanced pancreatic cancer: Oral communication presented by the French GERCOR Oncology Group, trial sponsor. ARTEMIA - International pivotal Phase 3 study in Non-Small Lung Cancer (NSCLC): Trial in Progress. NANTES, France – June 2, 2025, 6:00pm CET - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), today provided clinical updates on Tedopi®, the 'off-the-shelf' neo-epitope-based therapeutic cancer vaccine under evaluation in both monotherapy and combination therapy across five clinical trials in several cancer indications. Silvia Comis, MD, Chief Clinical and Medical Research Officer OSE Immunotherapeutics, commented: 'We are pleased to share the latest clinical updates on our cancer vaccine Tedopi® at the ASCO Annual Meeting. Tedopi® combines 10 neo-epitopes derived from five tumor antigens, selected for their presence in a range of tumors, offering a multi-target 'pipeline in a product' approach for HLA-A2 positive patients to address unmet needs in oncology. The positive results for Tedopi® in pancreatic cancer are promising for this devastating disease with a poor prognosis. We extend our gratitude to the GERCOR Oncology Group and the PRODIGE Intergroup, sponsors of the TEDOPaM study, for presenting these encouraging results at ASCO. In lung cancer, patient recruitment is progressing per plan in the Artemia Phase 3 registration study, a key milestone bringing us one step closer to the registration of Tedopi® for NSCLC. As previously communicated, the readouts of the combination Phase 2 trials, CombiTED for NSCLC and TEDOVA for ovarian cancer, are expected in 2026.' TEDOPaM - An oral communication, titled (abstract 4009) featuring positive topline Phase 2 results for the clinical trial TEDOPaM was presented by the GERCOR Oncology Group at ASCO 2025. TEDOPaM is a randomized, non-comparative, Phase 2 trial evaluating FOLFIRI1 (Arm A) and cancer vaccine Tedopi® (OSE2101) plus FOLFIRI chemotherapy (Arm B) as maintenance treatment in HLA-A2 positive patients with advanced or metastatic Pancreatic Ductal Adenocarcinoma (PDAC) with no progression after eight cycles of FOLFIRINOX induction chemotherapy2. The primary endpoint of the trial was the one-year overall survival (OS) rate in the experimental Arm B (Fleming 2-stage design, H0: 25%; H1: 50%, 1-sided alpha: 2.5%, power: 90%). 107 patients (53 patients in Arm A and 54 patients in Arm B) were enrolled (NCT03806309). The TEDOPaM trial met its primary objective, showing positive outcomes according to the predefined statistical hypothesis, with a 12-month OS of 65% in Arm B, and minimal toxicity for Tedopi® combined with FOLFIRI as maintenance treatment. Two complete responses were observed when adding Tedopi®. No new safety signal was observed. Prof. Cindy Neuzillet, MD, PhD (Curie Cancer Research Institute, Saint-Cloud), Principal Investigator of the TEDOPaM study stated: 'These results are an encouraging first step towards better understanding the contribution of Tedopi® in combination therapy in advanced pancreatic cancer. We now need more mature data on overall survival over a longer period. A translational and biomarker program is also underway to identify patient profiles likely to benefit from this maintenance treatment involving a neo-epitope-based cancer vaccine. Thanks to the digestive oncology community for their support in this research, which helps us better understand this disease.' Detailed results: A total of 107 patients were randomized between April 2021 and May 2023. The median age was 64 years, with 53% men and 69% having metastases. The median number of Tedopi® injections was 7.5. At the data cut-off on December 9, 2024, the median follow-up was 21 months. The TEDOPaM study met its primary endpoint: M12-OS was 65% in Arm B (FOLFIRI + Tedopi®). With a median follow-up of 21 months, around 35% of death events were observed. An unexpectedly long OS was observed in these PDAC patients with disease control after induction FOLFIRINOX: median OS of 17 months in control Arm A (versus 10-12 months expected). Two complete responses were observed when adding Tedopi® in Arm B, and none in control Arm A with chemotherapy alone. Safety: 26% in Arm B reported serious adverse events (SAEs). 6% related to Tedopi®. No new safety signal was reported. Further follow-up for OS and safety data is ongoing. A comprehensive translational analysis (IMMUNOPANC-Sign program) is ongoing. ARTEMIA - A 'Trial in Progress' poster titled: was also presented at ASCO 2025. The Phase 3 pivotal clinical trial aims to support the registration of Tedopi® as a second-line treatment in HLA-A2 positive NSCLC patients with secondary resistance to anti-PD-(L)1 immunotherapy. This pivotal trial is conducted in 14 countries across the United States, Canada, Europe, and United Kingdom. ARTEMIA will include 363 patients and enrolment is progressing according to the study program (NCT06472245). ABOUT RESECTED PANCREATIC DUCTAL ADENOCARCINOMA (PDAC). Resected pancreatic ductal adenocarcinoma (PDAC) is a highly aggressive form of cancer originating in the ducts of the pancreas. It represents about 95% of all pancreatic cancers. The global burden of pancreatic cancer has more than doubled in recent decades. It is now the sixth leading cause of cancer-related death worldwide, with an estimated 510,922 new cases and 467,409 deaths in 2022. The incidence of the disease continues to rise annually, with projections indicating a 95.4% increase in new cases by 2050, potentially reaching a total of 998,663 new cases globally. The overall five-year survival rate for pancreatic cancer is 10% worldwide, with only modest improvement in the past decade3. Pancreatic cancer is now the 10th most found cancer in the US4 and represents about 3.5% of all new cancer diagnoses, and 7.1% of all cancer deaths in the EU5. Surgical resection is the only potential curative treatment for PDAC, but it's feasible for only 15-20% of patients at diagnosis due to the advanced stage of their disease6. Even with successful surgery, the prognosis remains poor, with a high likelihood of recurrence. Advances in neoadjuvant therapies, which are treatments given before surgery, have improved the chances of achieving a margin-negative resection, meaning no cancer cells are found at the outer edge of the removed tissue. However, long-term survival rates remain low, underscoring the need for continued research and development of more effective systemic therapies to improve outcomes for patients with resected PDAC7. ABOUT GERCOR GERCOR is a multidisciplinary association dedicated to clinical research in oncology whose purpose is to improve the care of patients affected by cancer by developing clinical research in the scope of an independent, multidisciplinary and multi-focused cooperative group. GERCOR concentrates its efforts on only one mission: clinical research. Thanks to its network, GERCOR offers patients easy access to its up-to-date treatments. To achieve this goal, GERCOR has all the logistical structure needed to carry out the trials it promotes. ABOUT OSE IMMUNOTHERAPEUTICS OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I) that address the unmet patient needs of today and tomorrow. We partner with leading academic institutions and biopharmaceutical companies in our efforts to develop and bring to the market transformative medicines for people with serious diseases. OSE Immunotherapeutics is based between Nantes and Paris and is quoted on information about OSE Immunotherapeutics assets is available on the Company's website: Follow us on LinkedInContacts Fiona Dé French Media Contact FP2COMFlorence Portejoiefportejoie@ 6 07 768 283 U.S. Media ContactRooney Partners LLCKate Barrettekbarrette@ 212 223 0561 Forward-looking statementsThis press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics' management considering its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as 'expect', 'anticipate', 'believe', 'target', 'plan', or 'estimate', their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics' shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on April 30, 2025, including the annual financial report for the fiscal year 2024, available on the OSE Immunotherapeutics' website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements. 1 FOLFIRI: A combination chemotherapy with folinic acid, fluorouracil and irinotecan2 FOLFIRINOX: A combination chemotherapy with folinic acid, fluorouracil, irinotecan and oxaliplatin3 Trends in the Global Incidence of Pancreatic Cancer and a Brief Review of its Histologic and Molecular Subtypes | Journal of Gastrointestinal Cancer4 American Cancer Society: Annual Cancer Facts & Figures | American Cancer Society | American Cancer Society5 European Network of Cancer Registries: Pancreatic_Cancer_2022_ENG.pdf6 A neoadjuvant therapy compatible prognostic staging for resected pancreatic ductal adenocarcinoma | BMC Cancer | Full Text7 A neoadjuvant therapy compatible prognostic staging for resected pancreatic ductal adenocarcinoma | BMC Cancer | Full Text Attachments EN_250602_Post ASCO_vf EN_250602_Post ASCO_vfError in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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OSE Immunotherapeutics Announces that its Partner Boehringer Ingelheim Will Present Early Clinical Evidence of Innate Immune Modulation and Anti-Tumor Activity via SIRPα Blockade in Two Ongoing Trials at ASCO 2025
OSE Immunotherapeutics Announces that its Partner Boehringer Ingelheim Will Present Early Clinical Evidence of Innate Immune Modulation and Anti-Tumor Activity via SIRPα Blockade in Two Ongoing Trials at ASCO 2025 BI 765063 in combination with programmed cell death-1 (PD1) inhibitor antibody ezabenlimab + cetuximab demonstrated a well-tolerated safety profile and potentially promising efficacy signals as second-line treatment in patients with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Next generation SIRPα inhibitor BI 770371 was shown to be well tolerated alone and in combination with PD1 inhibitor ezabenlimab in a dose escalation trial in patients with advanced solid tumors. BI 770371 is currently being further investigated in a Phase 1b study in first-line patients with R/M HNSCC. Nantes, France, 23 May 2025 – OSE Immunotherapeutics (ISIN: FR0012127173; Mnemo: OSE), today proudly announced that its partner Boehringer Ingelheim will present new clinical data from two early-stage trials targeting the signal regulatory protein α (SIRPα) innate immune checkpoint at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, May 30 - June 3, 2025, in Chicago, IL, USA. In a Phase 1b study conducted by Boehringer, its potential, first-in-class SIRPα monoclonal antibody, BI 765063, demonstrated a manageable safety profile as well as preliminary signs of immune activation and additive antitumor activity when combined with PD-1 inhibitor ezabenlimab and cetuximab in patients with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).1 Additionally, in an open-label, Phase I trial conducted by Boehringer, its next-generation SIRPα monoclonal antibody, BI 770371, alone and in combination with the PD-1 inhibitor ezabenlimab, was shown to be well tolerated in patients with advanced solid tumors. There were no dose-limiting toxicities in either treatment arm, and the maximum tolerated dose was not reached in either group.2 'The preliminary results from these early-stage programs are encouraging and further strengthen Boehringer's robust immuno-oncology pipeline aimed at accelerating next-generation cancer therapies to address high unmet patient needs,' said Mike Akimov, Head of Medicine, Therapy Area Oncology at Boehringer Ingelheim. 'Boehringer is developing various complementary approaches to activate the immune system against cancer cells and SIRPα blockade paired with a PD-1 inhibitor is a promising strategy. We look forward to seeing if this dual activation may lead to a broader and more sustained anti-tumor response as the programs progress.' BI 765063 and BI 770371 are designed to block the 'don't eat me' signal that cancer cells use to hide from the immune system. By targeting SIRPα, these antibodies help immune cells like macrophages recognize and destroy tumor cells, bolstering the body's natural defenses.3 Both antibodies have been developed in partnership with OSE Immunotherapeutics, with Boehringer solely responsible for future clinical development and commercialization. Boehringer will move forward with the improved next generation SIRPα inhibitor antibody BI 770371, which will now be tested in a Phase 1b study. Presentation Details: Title: An Open-Label, Phase Ib Trial of the SIRPα Inhibitor BI 765063 in Combination with the PD-1 Inhibitor Ezabenlimab and Cetuximab in Patients (pts) with Head and Neck Squamous Cell Carcinoma Abstract Number: 6019Session Type/Title: Rapid Oral Abstract – Developmental Therapeutics – ImmunotherapyDate/Time: 01 June 2025 – 11:30am – 1:30pm CDT Title: An Open-label, Phase I Trial of the SIRPα Monoclonal Antibody, BI 770371, Alone and in Combination with the PD-1 Inhibitor Ezabenlimab in Patients with Advanced Solid TumorsAbstract Number: 2515Session Type/Title: Rapid Oral Abstract – Developmental Therapeutics – ImmunotherapyDate/Time: 01 June 2025 – 11:15am – 12:45pm CDT Boehringer Ingelheim Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer Ingelheim takes a long-term perspective, embedding sustainability along the entire value chain. More than 54,400 employees serve over 130 markets to build a healthier, more sustainable and equitable tomorrow. Learn more at (Global). OSE ImmunotherapeuticsOSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I) that address the unmet patient needs of today and tomorrow. We partner with leading academic institutions and biopharmaceutical companies in our efforts to develop and bring to the market transformative medicines for people with serious diseases. OSE Immunotherapeutics is based between Nantes and Paris and is quoted on Euronext. Additional information about OSE Immunotherapeutics assets is available on the Company's website: Click and follow us on LinkedIn. Contacts Boehringer Ingelheim Linda Ruckel+1 Reinhard Malin+49 (6132) OSE ImmunotherapeuticsFiona Dé French Media Contact FP2COMFlorence Portejoiefportejoie@ 6 07 768 283 U.S. Media ContactRooney Partners LLCKate Barrettekbarrette@ 212 223 0561 Forward-looking statementsThis press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics' management considering its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as 'expect', 'anticipate', 'believe', 'target', 'plan', or 'estimate', their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics' shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on April 30, 2025, including the annual financial report for the fiscal year 2024, available on the OSE Immunotherapeutics' website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements. 1 Link to the abstract2 Link to the abstract 3 Lopez-Yrigoyen, M., et al. (2017). Anti-SIRPα antibody immunotherapy enhances neutrophil and macrophage antitumor activity. Proceedings of the National Academy of Sciences, 114(33), 201710877. Attachment EN_250523_ASCO BI_OSE_vfError in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
